Eyenovia Reports First Quarter 2021 Financial Results

Rhea-AI Summary

Eyenovia, Inc. (NASDAQ: EYEN) announced key developments on May 12, 2021, including the confirmation of its PDUFA date for MydCombi as October 28, 2021. The company completed patient enrollment in its Phase 3 VISION-1 study for MicroLine, with top-line data expected soon. Financial results showed a net loss of $5.4 million for Q1 2021, slightly reduced from $5.5 million in Q1 2020. Eyenovia secured a $25 million credit facility with Silicon Valley Bank to support ongoing operations.

Positive

• Confirmed PDUFA date for MydCombi on October 28, 2021.
• Completed patient enrollment in Phase 3 VISION-1 study.
• Secured $25 million credit facility to support operations.
• License fee revenue of $2 million from Arctic Vision.

Negative

• Net loss increased to $5.4 million for Q1 2021.
• R&D expenses increased by 16.9% year-over-year to $4.2 million.
• G&A expenses rose by 25.2% year-over-year to $2.3 million.

MydCombi PDUFA date confirmed for October 28, 2021

Completed patient enrollment in Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia; top-line data on track for Q2

Secures $25 million credit facility through Silicon Valley Bank

Company to host conference call and webcast today, May 12, at 4:30pm ET

NEW YORK, May 12, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial results for the first quarter ended March 31, 2021.

First Quarter 2021 and Recent Business Highlights

• U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for the Company’s pupil dilation agent MydCombi™ and has notified the Company that the PDUFA date is confirmed for October 28, 2021.
• Secured new $25 million credit facility through Silicon Valley Bank (SVB).
• Completed patient enrollment in the Company’s Phase 3 VISION-1 study of MicroLine for the improvement in near vision in patients with presbyopia and anticipates top-line results in the coming weeks. Results from VISION-1 will help inform the design of a planned second Phase 3 study, VISION-2.
• Announced an exclusive partnership agreement with EVERSANA, a leading commercial service provider to the life science industry, to help commercialize and distribute MydCombi in the United States.
• Appointed Dr. Julia Haller, renowned ophthalmologist and scientific leader, to Eyenovia’s Board of Directors.
  

Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia, commented, “The Eyenovia team has made substantial progress in advancing towards its clinical, regulatory, and commercial goals during the first quarter of 2021. We look forward to our PDUFA date for MydCombi on October 28^th of this year. In preparation for the anticipated approval, we were pleased to announce an exclusive agreement with EVERSANA to help lead distribution of MydCombi in the United States.  If approved, MydCombi would be the first microdosed ocular therapeutic applied with our proprietary high precision smart delivery system, the Optejet®.”

“Regarding our Phase 3 VISION-1 clinical study evaluating our proprietary pilocarpine formulation, MicroLine, which is also delivered via the Optejet, for the improvement of near vision in patients with presbyopia, we have completed patient enrollment and anticipate top-line results in the coming weeks. We remain focused on advancing our late-stage clinical programs, while preparing to transition into a commercial-stage ophthalmology company. I believe we have set the stage for a transformational year in 2021,” concluded Dr. Ianchulev.

First Quarter 2021 Financial Review

For the first quarter of 2021, net loss was approximately $5.4 million, or $(0.21) per share, compared to a net loss of approximately $5.5 million, or $(0.31) per share, for the first quarter of 2020.

For the first quarter of 2021, the Company reported license fee revenue of $2.0 million from its license agreement with Arctic Vision (Hong Kong) Limited and a corresponding cost of revenue representing payments to Senju Pharmaceutical Co., Ltd. of $800,000.

Research and development expenses totaled approximately $4.2 million for the first quarter of 2021, compared to approximately $3.6 million for the same period in 2020, an increase of approximately 16.9%.

For the first quarter of 2021, general and administrative expenses were approximately $2.3 million compared to approximately $1.8 million for the first quarter of 2020, an increase of approximately 25.2%.

Total operating expenses for the first quarter of 2021 were approximately $6.5 million, compared to total operating expenses of approximately $5.5 million for the same period in 2020, an increase of approximately 19.7%.

As of March 31, 2021, the Company’s cash balance was approximately $24.9 million. Subsequent to the end of the first quarter, the Company announced a credit facility of up to $25 million through Silicon Valley Bank (SVB). The first tranche of $7.5 million was advanced to Eyenovia upon closing of the facility. The remaining two tranches ($7.5 million and $10.0 million) will be available to the Company subject to the satisfaction of certain milestones and covenants as outlined in the credit agreement.

Conference Call and Webcast

The conference call is scheduled to begin at 4:30pm ET on Wednesday, May 12, 2021. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international) with the conference code 13718776. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.eyenovia.com.

After the live webcast, the event will be archived on Eyenovia’s website for one year.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology. Eyenovia is currently focused on the late-stage development of medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.

About MicroLine for Presbyopia

MicroLine is a pharmacologic treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the Company’s high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability and usability.

About MicroPine for Progressive Myopia

MicroPine (atropine ophthalmic solution) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure.   MicroPine has been licensed to Bausch Health Companies, Inc. in the United States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.

About MicroStat (MyCombi™) for Mydriasis

MydCombi is Eyenovia's first-in-class fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed for use without anesthetic, Eyenovia is developing MicroStat to help improve the efficacy and tolerability of pharmacologic mydriasis.

About Optejet^® and Microdose Array Print (MAP™) Therapeutics

Eyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet is less than 75% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.

Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated regulatory review timing, and market opportunities for our product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: fluctuations in our financial results; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions; reliance on third parties; risks of our and our licensees’ clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the potential impacts of COVID-19 on our supply chain; the timing and our and our licensees’ ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; reliance on third parties to develop and commercialize certain of our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for certain of our product candidates; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; intellectual property risks; our ability to attract and retain key personnel; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.

Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com

Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363

Eyenovia Media Contact:
Sam Choinski
Pazanga Health Communications
schoinski@pazangahealth.com
(603) 489-5964

EYENOVIA, INC.
Condensed Balance Sheets
				March 31,				December 31,
					2021				2020
				(unaudited)
Assets
Current Assets:
	Cash and cash equivalents			$	24,907,048			$	28,371,828
	Deferred license costs				800,000				1,600,000
	License fee and expense reimbursements receivables				908,231				2,966,039
	Prepaid expenses and other current assets				1,409,929				453,478
		Total Current Assets			28,025,208				33,391,345
Property and equipment, net					707,419				396,380
Security deposit					119,035				119,035
		Total Assets		$	28,851,662			$	33,906,760
Liabilities and Stockholders' Equity
Current Liabilities:
	Accounts payable			$	1,815,117			$	1,461,665
	Accrued compensation				570,732				1,150,672
	Accrued expenses and other current liabilities				1,189,092				1,480,692
	Deferred rent - current portion				6,857				7,809
	Deferred license fee				12,000,000				14,000,000
	Notes payable - current portion				783,818				97,539
		Total Current Liabilities			16,365,616				18,198,377
Deferred rent - non-current portion					38,634				38,684
Notes payable - non-current portion					307,291				365,814
		Total Liabilities			16,711,541				18,602,875
Commitments and contingencies
Stockholders' Equity:
	Preferred stock, $0.0001 par value, 6,000,000 shares authorized;
	0 shares issued and outstanding as of March 31, 2021 and
	December 31, 2020, respectively				-				-
	Common stock, $0.0001 par value, 90,000,000 shares authorized;
	25,623,577 and 24,978,585 shares issued and outstanding
	as of March 31, 2021 and December 31, 2020, respectively				2,563				2,498
	Additional paid-in capital				94,930,144				92,742,306
	Accumulated deficit				(82,792,586	)			(77,440,919	)
		Total Stockholders' Equity			12,140,121				15,303,885
		Total Liabilities and Stockholders' Equity		$	28,851,662			$	33,906,760

EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
				For the Three Months Ended
				March 31,
					2021				2020
Operating Income
	Revenue			$	2,000,000			$	-
	Cost of revenue				(800,000	)			-
		Gross Profit			1,200,000				-
Operating Expenses:
	Research and development				4,247,726				3,634,287
	General and administrative				2,300,327				1,836,782
		Total Operating Expenses			6,548,053				5,471,069
		Loss From Operations			(5,348,053	)			(5,471,069	)
Other Income (Expense):
	Interest expense				(5,148	)			(3,681	)
	Interest income				1,534				23,840
		Net Loss		$	(5,351,667	)		$	(5,450,910	)
		Net Loss Per Share
		- Basic and Diluted		$	(0.21	)		$	(0.31	)
		Weighted Average Number of
		Common Shares Outstanding
		- Basic and Diluted			25,330,563				17,308,804

FAQ

What is the significance of the PDUFA date for EYEN's MydCombi?

The PDUFA date of October 28, 2021, is critical as it marks the FDA's deadline to decide on the approval of MydCombi, potentially impacting EYEN's market position.

What are the recent financial results for Eyenovia?

For Q1 2021, Eyenovia reported a net loss of $5.4 million, with increased research and administrative expenses compared to the previous year.

What are the expectations for the VISION-1 study results?

Eyenovia expects to announce top-line results from the Phase 3 VISION-1 study evaluating MicroLine for presbyopia in the coming weeks.

What financial support has Eyenovia secured recently?

Eyenovia secured a $25 million credit facility from Silicon Valley Bank to bolster its financial position.